ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000600741

Ethics application status

Approved

Date submitted

30/04/2013

Date registered

27/05/2013

Date last updated

7/12/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Post tonsillectomy pain control – a double blinded , randomised, prospective study

Scientific title

Does the use of COX-2 inhibitors Celecoxib (Celebrex(Trademark) improve the outcome of post tonsillectomy pain? A double-blinded randomised control study in patients over 18 years of age.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1142-4978

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tonsillitis

Condition category

Condition code

Surgery

Other surgery

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The administration of a non-steroidal anti-inflammatory drugs, celecoxib,( Celebrex(trademark)) , for the control of post tonsillectomy pain
Post operatively, patients will receive regular analgesics routinely given to post tonsillectomy patients. with allowance for IV Morphine as rescue analgesia, Ondansetron / Maxalon Metoclopramide (taken orally) as antiemetic and other medications deemed necessary..
2 doses of IV Dexamethasone 8mg will be given to all patients post-operatively and on the first morning post surgery.
Upon discharge patients will be supplied with a treatment or placebo pack. Both packs contain
Paracetamol (1gm (4 times per day) 12 days), Penicillin (500mg (twice per day) 5 days), endone (5mg (as required) /6 hrly) and either Placebo (2 capsules (twice per day) 7 days) OR Celecoxib ((200 mg capsules), 2 capsules (twice per day), 7 days)). All medications are taken orally
Study participants will be asked to return all unused medications to the study coordinator at the final outpatient appointment. These will be checked against their patient drug diary to ensure protocol adherence.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo - lactose powder filled capsule

Control group

Placebo

Outcomes

Primary outcome [1]

Is Celecoxib a useful adjunct in post tonsillectomy pain control? Assessed using all the outcomes listed
Pain is scored using a 1 - 10 numeric scale (0 being no pain and 10 being worst pain) recorded in a patient diary. The diary is completed at the same time everyday (at the time of the evening meal) and is assessed when resting, drinking and eating.

Timepoint [1]

28 days

Primary outcome [2]

Does Celecoxib have more incidence of post tonsillectomy haemorrhage?
Measured on a 3 point haemorrhage scale
1. No bleeding
2. Minimal bleeding - managed medically with no blood transfusion
3. Profuse bleeding - requiring theatre admission or blood transfusion

Timepoint [2]

28 days

Primary outcome [3]

Is the pain free day earlier in the drug or placebo group? Pain free day is the day when the patient scores the pain as a zero in their patient diary.

Timepoint [3]

28 days

Secondary outcome [1]

Is the readmission rate for dehydration or poor oral intake lower in the study group

Timepoint [1]

28 days

Secondary outcome [2]

Does the study group have less side effects e.g. Nausea, vomiting, constipation, drowsiness
Study participants are given a patient diary and asked to specify all side effects experienced

Timepoint [2]

28 days

Secondary outcome [3]

Does the study group take less rescue analgesics. This will be recorded in a diary given to all study participants.

Timepoint [3]

28 days

Eligibility

Key inclusion criteria

Over 18 years
Undergone a tonsillectomy

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(1) Other concomitant surgical procedures
(2) Allergic to NSAIDS/opioids/codeine/endone/paracetamol/sulphonamide
(3) Asthma
(4) Kidney disease
(5) Liver disease
(6) Cardiovascular disease
(7) Hemorrhagic disease
(8) Hypertension
(9) OSA
(10) Women trying to conceive, pregnant or nursing
(11) Patients taking clebrex

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients suitable for the trial will be invited to participate and consented appropriately. Drug allocation will be done by the pharmacist and both the patient and the research personnel will be blinded to allocation.
The drug regime includes Celecoxib (or placebo), paracetamol, endone (rescue analgesic), penicillin

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using computer software to generate a randomisation table

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2013

Actual

20/06/2013

Date of last participant enrolment

Anticipated

30/06/2015

Actual

29/04/2015

Date of last data collection

Anticipated

Actual

8/10/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Frankston Hospital - Frankston

Recruitment postcode(s) [1]

3199 - Frankston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Surgery
Frankston Hospital

Address [1]

PO Box 52
Frankston VIC 3199

Country [1]

Australia

Primary sponsor type

Hospital

Name

Department of Surgery Frankston Hospital

Address

PO Box 52
Frankston VIC 3199

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health Human Research Ethics Committee

Ethics committee address [1]

c/- Research program
Mount Eliza Centre
Jackson Road
Mount Eliza  VIC 3930

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/06/2013

Ethics approval number [1]

HREC/12/PH/55

Summary

Brief summary

This study looks at the treatment of post tonsillectomy pain.  The pain experienced is severe and has a tendency to get worse five to seven days after surgery.  This often has an impact on the patient’s oral intake prolonging the return to normal activity.  The narcotics given for pain control are often associated with side effects. 

Non-steroidal anti-inflammatory drugs, such as Celecoxib (Celebrex(trademark) are superior for the control of pain minus the side effects.  In this study the patient will be randomised to one of two groups and given a study pack on discharge.  Both packs contain an antibiotic (Penicillin) and a “rescue” analgesic (Oxycodone - Endone(Trademark) ). One pack contains paracetamol and one contains paracetamol and Celecoxib/Celebrex. 

Patients will be asked to chart their recovery until their pain ceases.  A data collection chart will be given to each patient on discharge.  Each patient will be followed up in outpatients 5 days and 4 weeks post-surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Diamanti Diamantaras

Address

Department of Surgery
Frankston Hospital
PO Box 52
Frankston VIC 3199

Country

Australia

Phone

61 3 97847777

Fax

ResearchEthics@phcn.vic.gov.au

Contact person for public queries

Name

Lee-Anne Clavarino

Address

Research Department
Peninsula Health
Mount Eliza Centre
Jacksons Road
Mount Eliza VIC 3930

Country

Australia

Phone

61 3 97881473

Fax

researchethics@phcn.vic.gov.au

Contact person for scientific queries

Name

Francis Ng

Address

Department of Surgery
Frankston Hospital
PO Box 52
Frankston VIC 3199

Country

Australia

Phone

61 3 97847777

Fax

tntdynamites@yahoo.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Is celecoxib a useful adjunct in the treatment of post-tonsillectomy pain in the adult population? A randomised, double-blind, placebo-controlled study.	2017	https://dx.doi.org/10.1017/S0022215116009476

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically